The FDA usually, but not always, follows the advice of its advisory panels. But the FDA has previously determined it may be appropriate to license biosimilars for additional conditions for which a branded product is approved, even if the biosimilar has not been tested for them. Steven Solga, head of gastroenterology at St. Luke's University Hospital in Bethlehem,...» Read More
Usually when a company announces an executive departure the news comes out in a press release with a header along the lines of , "So-and-so to retire, search begins for successor," or, "XYZ Corp. CEO resigns, interim CEO appointed," etc.
Some analysts had been telling clients recently that they thought Vivus' diet drug Qnexa could take the lead in the three-contestant race to get the next prescription diet pill on the market. But they didn't think it would take such a commanding lead.
Talk about a short tenure. Only eight months after Roche installed him as CEO of Genentech, Pascal Soriot is moving on (up?) to become COO of Roche's Pharma Division.
Lost in the coverage of the Pfizer-Wyeth deal that day, but nonetheless disclosed in the company's simultaneous earnings release back on January 26th of this year, PFE revealed it had taken a $2.3 billion charge for a pending settlement over marketing.
Virtually every large pharmaceutical company seems to have discovered cancer, and a substantial portion of the smaller biotechnology companies are focused on it as well. Together, the companies are pouring billions of dollars into developing cancer drugs.
After a long delay, Eli Lilly finally launched its new bloodthinner Effient just this month. But analysts are already buzzing about what's next.
Reading Betsy McCaughey’s op-ed article in today’s Wall Street Journal, I understand fully why the elderly are so scared about the possibility of a nationalized health care system.
British drugmaker GlaxoSmithKline is trying to keep from having to tighten its belt over new safety concerns with its weightloss pill, alli
Real choice is not part of the bills moving through the Democratic-led Congress; even if the much-debated government-run insurance plan was created, it would not be available to most people who already have coverage.
Am I missing something? Or is this not the way to go about advancing your cause?
A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies - articles that were carefully calibrated to help the manufacturers sell more products.
It sounds like a simple idea for improving health care: draw up guidelines on how best to treat a particular illness and then pay doctors to follow them. That strategy, which some insurers and health plans already employ, has been embraced during the health care debate by some lawmakers in Congress who want to extend it more broadly.
Before I go on vacation for a week I wanted to close the loop and offer some random thoughts on a few things.
Amid the ongoing healthcare reform brouhaha, pharma stocks are getting buffeted.
OK. I have to put aside the fact that he went to Notre Dame and is a diehard Fighting Irish fan (Go 'SC!), but Regis' trademark rant against Pfizer on "Fast Money" yesterday is too good not to blog it.
For years the Dendreon saga was centered around the controversy over whether its prostate cancer treatment worked or not. Well, now that we know the answer to that question the focus has turned to potential FDA approval of the therapeutic vaccine and the company's ability to make it and master the unique treatment process.
The House version of a Health Care overhaul bill will not stand up well in the August heat. It makes for scary reading and if the powers that be could have muscled it through it wouldn't be hanging in the wind for all of us to take shots at it. But there it is and it makes for head scratching moments. My friend, Sydney Williams, who writes one of the best investment letters I get to read, passed along some highlights that were extracted by a buddy of his, Peter Fleckenstein.
I know it's trite and cliche, but I learn something new almost every day on this beat. Take pseudobulbar affect. I'd never heard of it before. I had to Google it when I got a press release late yesterday announcing that Avanir Pharmaceuticals was going to unveil late-stage test results on a drug for it this morning.
Critics have been saying for years that big pharma's been pi..., er, throwing away money on relatively unproductive research and development of new drugs. But a new study shows urine could eventually provide a new revenue stream.
Remember 1993 and health care? It was doomed because Americans did not want Big Government running one more part of their lives. Why? Because Government doesn’t do things very well – it’s as simple as that.